EU Approves New Multi-Dose Vial of Prevenar 13 - Drug Discovery and Development

Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) approved a new four-dose, multi-dose vial (MDV) presentation of Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). This new MDV presentation was developed to help maximize efficiency for health care workers by helping to significantly reduce storage requirements and shipping costs in communities with health systems that are still developing.

The MDV presentation of Prevenar 13 offers significant benefits to developing countries, including a 75 percent reduction in:

Temperature-controlled supply chain requirements,
United Nations International Children’s Education Fund (UNICEF) shipping costs, and
Storage requirements at the national, regional, district, and community levels.

“Prevenar 13 is the first approved pneumococcal conjugate vaccine available in a preserved multi-dose vial presentation,” said Luis Jodar, Ph.D., global vice president, Vaccines, Pfizer Global Medicines Development Group and Medical/Scientific Affairs. “With this new presentation, a box that once carried enough vaccine to help protect 50 infants and children will potentially vaccinate 200, helping to ensure Prevenar 13® is accessible in the most remote regions of the world where the greatest burden of invasive pneumococcal disease lies.”

Pfizer plans to submit its Prevenar 13 MDV presentation to the World Health Organization (WHO) for prequalification, which, if and when approved, will allow for the global use of this new presentation of Prevenar 13® by United Nations agencies and countries worldwide that require WHO prequalification. If and when prequalified, the MDV presentation is expected to be introduced under the Advance Market Commitment program in early 2017, for shipment to countries covered by Gavi, the Vaccine Alliance (Gavi). This presentation will be available at a lower price of $3.10 per dose.

“Prevenar 13 formulated in multi-dose vials was studied in collaboration with the Medical Research Council Unit, The Gambia,” said William Gruber, M.D., Senior Vice President Vaccine Clinical Research and Development. “This multi-dose presentation of Prevenar 13® demonstrated a favorable safety profile and immune responses to help protect children from invasive pneumococcal disease due to serotypes contained in the vaccine.1”

Source: Pfizer